Drug · Small Molecule

Brigatinib

CI-DRUG-00000115Explore in graph →NCIt C98831 CHEMBL3545311 CIViC Approved

Regulatory

Approvals (9)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.	approved	Nov 22, 2018	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 11 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	7	3	2	27	9	CA, EU, US	Apr 28, 2017	Sep 20, 2011
Malignant Lung Neoplasm	Phase3	Phase 3	4	0	1	17	0	—	—	Sep 20, 2011
Non-Hodgkin Lymphoma	Phase2	Phase 2	1	1	0	2	0	—	—	Dec 6, 2018
Malignant Breast Neoplasm	Phase2	Phase 2	0	0	0	1	0	—

Curated evidence

Clinical evidence (21)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–21 of 21 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ALK Fusion5
Brigatinib	Inflammatory Myofibroblastic Tumor

Clinical trials

Trials with this intervention (34)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–34 of 34 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04374305	Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)(INTUITT-NF2)	recruiting	Phase 2	109	Scott R. Plotkin, MD, PhDOTHER	1	Sep 2, 2026	clinicaltrials
NCT04227028	Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC

Molecule

Record

Kind: Small Molecule
Mechanism: ALK tyrosine kinase receptor inhibitor; Epidermal growth factor receptor erbB1 inhibitor
Targets: 2 genes
UNII: HYW8DB273J
Aliases: (2-((5-Chloro-2-((2-methoxy-4-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)phenyl)amino)pyrimidin-4-yl)amino)phenyl)dimethyl-,delta5-phosphanone, 5-Chloro-N4-[2-(dimethylphosphoryl)phenyl]-N2-{2-methoxy-4[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}pyrimidine-2,4-diamine, Alunbrig, ALUNBRIG, AP 26113, AP-26113, AP26113, Biganib, Briganix, Brigatinib, BRIGATINIB (AP-26113), BRIGATINIB (AP26113), BRIGATINIBAP-26113AP26113CS-4278, Trepmac

Data updated 14 hours agoSource updated unknown

Identifiers

Codes (11)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01ED04	BRIGATINIB
ATC (WHO)	L01XE43

EGFR C797S2
Brigatinib + CetuximabCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	submitted	EID8028 Third generation EGFR inhibitor osimertinib can overcome the T790M resistance mutation on L858R or exon 19 del background. Drug screening of Ba/F3 cells expressing EGFR triple mutant (C797S/T790M/del1… (full text at CIViC) PMID 28287083 · Uchibori et al., 2017 · Open in CIViC	civic
Brigatinib + Cetuximab + PanitumumabCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	submitted	EID4837 Currently, there are no effective therapeutic strategies to overcome the C797S/T790M/activating-mutation (triple-mutation)-mediated EGFR-TKI resistance to Osimertinib. In the present study, we identif… (full text at CIViC) PMID 28287083 · Uchibori et al., 2017 · Open in CIViC	civic

EGFR C797S2

Brigatinib + CetuximabCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID8028

Third generation EGFR inhibitor osimertinib can overcome the T790M resistance mutation on L858R or exon 19 del background. Drug screening of Ba/F3 cells expressing EGFR triple mutant (C797S/T790M/del1… (full text at CIViC)

PMID 28287083 · Uchibori et al., 2017 · Open in CIViC